NCT00792103

Brief Summary

The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by:

  • Subject self-examination skin irritation scores
  • Adverse events
  • Changes in vital signs and ECG parameters The secondary objective is to evaluate the long term efficacy of NP101 as assessed by:
  • Headache pain free at two hours after patch activation for all initial acute migraine attacks treated with NP101
  • Headache pain relief at two hours after patch activation for all initial acute migraine attacks treated with NP101
  • Nausea free at two hours after patch activation for all initial acute migraine attacks treated with NP101
  • Phonophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
  • Photophobia free at two hours after patch activation for all initial acute migraine attacks treated with NP101
  • Migraine free at two hours after patch activation for all initial acute migraine attacks treated with NP101 This study will use an open-label design to assess the long term safety of NP101 (sumatriptan iontophoretic transdermal patch). Subjects who continue to be in good health (use of a triptan or use of an NP101 patch is not contraindicated) and received treatment (patch activation) with the study patch for a qualifying migraine under study NP101-007 will be considered eligible for enrollment into the open-label study. Subjects will be expected to remain in the study for up to 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 7, 2013

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

November 14, 2008

Results QC Date

February 15, 2013

Last Update Submit

February 2, 2016

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • Subject Self-examination of Skin Irritation

    For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).

    24 hours post patch activation

Secondary Outcomes (4)

  • Pain Relief

    2 hours

  • Nausea Free

    2 hours

  • Phonophobia Free

    2 hours

  • Photophobia Free

    2 hours

Study Arms (1)

NP101

EXPERIMENTAL

sumatriptan iontophoretic transdermal patch

Drug: NP101

Interventions

NP101DRUG

NP101 study patch 4 hour application

NP101

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject was previously enrolled in study NP101-007 and treated (patch activation) a qualifying migraine.
  • Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, and ECG. Subjects will not have any clinically significant abnormal vital signs or ECG parameters in order to qualify for enrollment. ECG must be done at enrollment for NP101-008 unless ECG for the Final Visit of study NP101-007 was conducted within 30 days.
  • Female subjects of childbearing potential (not surgically sterile or 2 years post menopausal) must have a negative pregnancy test at enrollment.

You may not qualify if:

  • Subject has less than two potential skin application sites.
  • Subject has clinically significant abnormal vital signs or ECG parameters or had an adverse event while participating in NP101-007 that would preclude the continued treatment with the NP101 patch.
  • Subject has had changes in their medical history or medication use that would preclude their use of sumatriptan as per the approved Imitrex® product Prescribing Information (PI) or their safe use of NP101 as per the NP101 Investigator's Brochure.
  • Subject has or plans to start, stop, change treatment or dose of any of the following within 3 months prior to the subject's study Enrollment date and through the Final Visit: anxiolytics, lithium and other mood stabilizers such as valproate, carbamazepine or lamotrigine, hypnotics or antipsychotics.
  • Subject has taken non-triptan serotonergic drugs including selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressants (TCAs), monoamine oxidase inhibitor (MAOI) or preparations containing St. John's Wort within 1 month prior to enrollment and/or is planning to start any of these medications during the study (through Final Visit).
  • Female subjects who are pregnant, breast feeding, or of childbearing potential, and are not using or are unwilling to use an effective form of contraception during the study and for a period of 30 days following Final Visit. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted or injected) or abstinence. If the exclusive male partner is surgically sterile, this will be acceptable.
  • Subject has participated in a clinical study within 30 days of enrollment (excluding NP101-007) or is planning to participate in another clinical study for the duration of NP101-008.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Fairfield, Connecticut, United States

Location

Unknown Facility

Ocala, Florida, United States

Location

Unknown Facility

Palm Beach Gardens, Florida, United States

Location

Unknown Facility

Sunrise, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Columbus, Georgia, United States

Location

Unknown Facility

Decatur, Georgia, United States

Location

Unknown Facility

Savannah, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Kalamazoo, Michigan, United States

Location

Unknown Facility

Springfield, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Mount Vernon, New York, United States

Location

Unknown Facility

Plainview, New York, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

West Chester, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Wynnewood, Pennsylvania, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

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Unknown Facility

Alexandria, Virginia, United States

Location

Unknown Facility

Virginia Beach, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Related Publications (1)

  • Smith TR, Goldstein J, Singer R, Pugach N, Silberstein S, Pierce MW. Twelve-month tolerability and efficacy study of NP101, the sumatriptan iontophoretic transdermal system. Headache. 2012 Apr;52(4):612-24. doi: 10.1111/j.1526-4610.2012.02094.x. Epub 2012 Feb 21.

    PMID: 22352764DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Mark Pierce, MD PhD
Organization
NuPathe Inc.
mpierce@nupathe.com
484-567-0130

Study Officials

  • Mark Pierce, MD PhD

    NuPathe Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 4, 2016

Results First Posted

May 7, 2013

Record last verified: 2016-02

Locations

US(34)